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International Consortium Awarded €6M to Validate Pre-Eclampsia Early Detection Tests

Cork, Ireland and Ghent, Belgium – 5 November 2012 – The European Union has awarded 6 million euro of research funding under the FP7-health framework to a consortium which is working to bring a predictive test for pre-eclampsia to market. The consortium is coordinated by Prof Louise Kenny at University College Cork, Ireland and driven by two companies, Pronota NV of Belgium and Metabolomic Diagnostics Ltd. of Ireland, both at the forefront in the discovery and development of novel blood-borne biomarkers for disease prediction.

The IMPROvED (IMproved PRegnancy Outcomes via Early Detection) project will establish a multicentre clinical study to assess and refine two innovative prototype screening tests for this common late pregnancy complication. These tests are based on proteomic and metabolomic profiles developed by the two companies.

Prof Louise Kenny, co-ordinating principal investigator of IMPROvED commented: “Pre-eclampsia is a very serious condition. It affects almost one in 20 first time mothers and globally causes approximately 70,000 maternal deaths each year. We were therefore extremely pleased to see that researchers from different fields, centres and countries were enthusiastic about the IMPROvED project. Our ultimate goal is to develop a robust predictive test for pre-eclampsia and to improve the outcome of pregnancy for both mothers and their babies.”

Katleen Verleysen, CEO of Pronota says: “A predictive test for pre-eclampsia, and in particular for preterm pre-eclampsia, will significantly improve maternal and fetal health. We are excited to be part of the consortium. The IMPROvED clinical trial will allow Pronota to progress its proteomics based risk stratification test.”

Charles Garvey, CEO of Metabolomics Diagnostics added: “Metabolomic Diagnostics, is delighted to be involved in this innovative consortium. We believe that an early pregnancy-screening test can make a major contribution to maternal safety and this project, once completed, will help accelerate its adoption.”

The four-year IMPROvED project will establish a high quality pregnancy biobank with blood samples collected from 5,000 first-time pregnant women recruited from at least five countries including Ireland, the United Kingdom, Germany, Sweden and the Netherlands. All recruitment centres involved (University College Cork, Erasmus University Rotterdam, Klinikum der Universität zu Köln, The University of Liverpool, Karolinska Institute, University of Keele) are major obstetric centres with a proven track record in the research and management of pre-eclampsia. The scientific value of the biobank will be enhanced by the collection and storage of comprehensive clinical data along with the samples (Medscinet AB, Sweden). Dedicated and independent teams of statisticians (Region Hovedstaden, Denmark) and economics (University of Groningen) will ascertain clinical and health economical validity of the developed proteomics and metabolomics tests.

Prof Phil Baker (Keele University), co-principal investigator, added: “An effective screening test will allow antenatal care to be tailored to an individual woman’s risk, such that at risk women receive the best possible care – so diminishing the burden of this potentially devastating disease. The approval of IMPROvED is a strong endorsement of European researchers and is recognising the importance of enhancing maternal and fetal health.”

Pre-eclampsia is a complex pregnancy complication whereby high blood pressure arises in the second half of pregnancy. The condition is associated globally with 70,000-80,000 maternal and over 500,000 infant deaths annually. For the mother it can lead to acute problems in the liver, kidneys, brain and the clotting system, and pre-eclampsia is the most important cause of maternal death in Europe - accounting for 17-24% of all maternal deaths. Every year, an estimated €31 billion is spent in the developed world on direct healthcare costs to provide antenatal care for nulliparous women and treatment for pre-eclampsia; of this, an estimated €9 billion is spent in Europe. An effective screening test would facilitate stratification and targeting of limited resources and there is therefore a compelling health economic argument for an effective, early, pre-eclampsia prediction test.

About the consortium

The consortium is made up of specialists from University of Cork, Ireland; Accelopment AG, Switzerland; Erasmus University Rotterdam, The Netherlands; Karolinska Institute, Sweden; University of Keele, UK; Medscinet AB, Sweden; Metabolomic Diagnotics Ltd, Ireland; Pronota, Belgium; Region Hovedstaden, Denmark; University of Groningen, The Netherlands; Klinikum der Universitaet zu Koeln, Germany and the University of Liverpool, UK.

Pronota NV is developing and commercialising first-in-class diagnostics for early detection of life-threatening conditions and unmet medical needs including pre-eclampsia, ovarian cancer, sepsis and in the cardio-renal area. Our non-invasive, validated, diagnostics are proprietary and focused on improving quality of care for patients. Backed by a solid base of investors including GIMV, LSP, KBC Private Equity and JJDC, and a wide network of renowned key opinion leaders, Pronota is committed to making a difference in diagnosis and personalized healthcare.

Metabolomic Diagnostics Ltd. is an innovative medical diagnostics company involved in the development of a breakthrough technology to provide an early pregnancy screening test for pre-eclampsia. This technology has the potential to revolutionise prenatal care globally, significantly improving outcomes and dramatically reducing overall healthcare costs.

About University College Cork

University College Cork (UCC) is an internationally competitive, research-led University that was named Irish University of the Year by the Sunday Times in 2003, 2005, and 2011. In 2011, the QS World University Rankings ranked the university amongst the top 2% of universities worldwide. Our research strategy is focused on creating major centres of excellence for world-class research and despite adverse economic conditions, new awards from the EU increased by 275% (to €13.3 million) in 2009-2010. Perinatal Translational Research is a key strategic focus and this is led by Prof Louise Kenny, a former Health Research Board Clinician Scientist and current Science Foundation Ireland Principal Investigator. Work from Prof Kenny’s group underpins the metabolomic biomarkers being tested in this new FP7 funded study.